mp-441 - mp-441 - Medical Policies
Cardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient Setting
Policy Number: MP-441
Latest Review Date: June 2020
Policy Grade: B
In the ambulatory care and outpatient setting, cardiac hemodynamic monitoring for the management of heart failure utilizing non-invasive pulmonary fluid monitoring, thoracic bioimpedance, inert gas rebreathing, arterial pressure/Valsalva, and implantable direct pressure monitoring of the pulmonary artery is considered not medically necessary and investigational.
DESCRIPTION OF PROCEDURE OR SERVICE:
A variety of outpatient cardiac hemodynamic monitoring devices are intended to improve quality of life and reduce morbidity for patients with heart failure by decreasing episodes of acute decompensation. Monitors can identify physiologic changes that precede clinical symptoms and thus allow preventive intervention. These devices operate through a variety of mechanisms, including implantable pressure sensors, thoracic bioimpedance measurement, inert gas rebreathing, and estimation of left ventricular end diastolic pressure by arterial pressure during the Valsalva maneuver.
Chronic Heart Failure
Patients with chronic heart failure are at risk of developing acute decompensated heart failure, often requiring hospital admission. Patients with a history of acute decompensation have the additional risk of future episodes of decompensation, and death. Reasons for the transition from a stable, chronic state to an acute, decompensated state include disease progression, as well as acute events such as coronary ischemia and dysrhythmias. While precipitating factors are frequently not identified, the most common preventable cause is noncompliance with medication and dietary regimens.
Strategies for reducing decompensation, and thus the need for hospitalization, are aimed at early identification of patients at risk for imminent decompensation. Programs for early identification of heart failure are characterized by frequent contact with patients to review signs and symptoms with a healthcare provider, education and adjustment of medications as appropriate. These encounters may occur face-to-face in the office or at home, or via cellular or computed technology.
Precise measurement of cardiac hemodynamics is often employed in the intensive care setting to carefully manage fluid status in acutely decompensated heart failure. Transthoracic echocardiography, transesophageal echocardiography (TEE), and Doppler ultrasound are noninvasive methods for monitoring cardiac output on an intermittent basis for the more stable patient but are not addressed herein. A variety of biomarkers and radiological techniques may be used for dyspnea when the diagnosis of acute decompensated heart failure is uncertain.
The criterion standard for hemodynamic monitoring is pulmonary artery catheters and central venous pressure catheters. However, they are invasive, inaccurate and inconsistent in predicting fluid responsiveness. Several studies have demonstrated that catheters fail to improve outcome in critically ill patients and may be associated with harm. To overcome these limitations, multiple techniques and devices have been developed that use complex imaging technology and computer algorithms to estimate fluid responsiveness, volume status, cardiac output and tissue perfusion. Many are intended to be used in outpatient setting but can be used in the emergency department, intensive care unit, and operating room. Five methods are reviewed here: implantable pressure monitoring devices, non-invasive pulmonary fluid monitoring, thoracic bioimpedance, inert gas rebreathing, and arterial waveform during the Valsalva maneuver. The use of last 3 is not widespread because of several limitations including use of proprietary technology making it difficult to confirm their validity and lack of large randomized controlled trials to evaluate treatment decisions guided by these hemodynamic monitors.
This policy refers only to the use of stand-alone cardiac output measurement devices designed for use in ambulatory care and outpatient settings. The use of cardiac hemodynamic monitors or intrathoracic fluid monitors that are integrated into other implantable cardiac devices, including implantable cardioverter defibrillators, cardiac resynchronization therapy devices, and cardiac pacing devices, is addressed in medical policy # 055 – Biventricular Pacemakers (Cardiac Resynchronization Therapy) for the Treatment of Heart Failure.
The most recent literature review was updated through March 9, 2020.
Summary of Evidence
For individuals who have heart failure in outpatient settings who receive hemodynamic monitoring with an implantable pulmonary artery pressure sensor device, the evidence includes randomized controlled trials (RCTs). Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, morbid events, hospitalizations, and treatment-related morbidity. One implantable pressure monitor, the CardioMEMS device, has U.S. Food and Drug Administration approval. The pivotal CHAMPION RCT reported a statistically significant decrease in heart failure-related hospitalizations in patients implanted with CardioMEMS device compared with usual care. However, the results were potentially biased in favor of the treatment group due to use of additional nurse communication to enhance protocol compliance with the device. The manufacture conducted multiple analyses to address the issue of potential bias from the nurse interventions. These were reviewed favorably by FDA. While these analyses demonstrated consistency of benefit from the CardioMEMS device, all such analyses have methodologic limitations. Early safety data is suggestive of a higher rate of procedural complications, particularly related to pulmonary artery injury. Given that the intervention is invasive, intended to be used for a highly prevalent condition, in the light of limited safety data, lack of demonstrable mortality benefit and pending questions related to its benefit for reduction in hospitalization, the net benefit remains uncertain. Many of these issues may be clarified from the results of an ongoing postmarketing study that is currently ongoing and proposes to enroll 1200 patients with at least 35% women. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals who have heart failure in outpatient setting who receive hemodynamic monitoring by thoracic bioimpedance, the evidence includes uncontrolled prospective studies and case series. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, morbid events, hospitalizations, and treatment-related morbidity. There is a lack of RCT evidence evaluating whether use of these technologies improves health outcomes over standard active management of heart failure patients. The case series have reported physiologic measurement-related outcomes and/or associations between monitoring information and heart failure exacerbations, but do not provide definitive evidence on device efficacy. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals who have heart failure in outpatient settings who receive hemodynamic monitoring with inert gas rebreathing or non-invasive pulmonary fluid monitoring, no studies have been identified on clinical validity or clinical utility. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, morbid events, hospitalizations, and treatment-related morbidity. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals who have heart failure in outpatient settings who receive hemodynamic monitoring of arterial pressure during the Valsalva maneuver, a single study was identified. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, morbid events, hospitalizations, and treatment-related morbidity. The study assessed the use of LVEDP monitoring and reported an 85% sensitivity and an 80% specificity to detect LVEDP greater than 15 mm Hg. The evidence is insufficient to determine the effects of the technology on health outcomes.
Practice Guidelines and Positions Statements
American College of Cardiology et al
The 2017 joint guidelines by the American College of Cardiology, American Heart Association, and Heart Failure Society of America issued joint guidelines on the management of heart failure that offered no recommendations for use of ambulatory monitoring devices.
European Society of Cardiology
The European Society of Cardiology guidelines on the diagnosis and treatment of acute and chronic heart failure state the following: “Monitoring of pulmonary artery pressures using a wireless implantable hemodynamic monitoring system (CardioMEMS) may be considered in symptomatic patients with heart failure with previous heart failure hospitalization in order to reduce the risk of recurrent heart failure hospitalization (Class IIb Level B recommendation).”
National Institute for Health and Clinical Excellence
The updated 2018 guidance from the National Institute for Health and Care Excellence (NICE) on chronic heart failure management did not include outpatient hemodynamic monitoring as a recommendation.
In 2013, NICE issued guidance on the insertion and use of implantable pulmonary artery pressure monitors in chronic heart failure. The recommendations concluded that “Current evidence on the safety and efficacy of the insertion and use of implantable pulmonary artery pressure monitors in chronic heart failure is limited in both quality and quantity.”
Heart Failure Society of America
In 2018, the Heart Failure Society of America Scientific Statements Committee published a white paper consensus statement on remote monitoring of patients with heart failure.
The committee concluded that: "Based on available evidence, routine use of external RPM devices is not recommended. Implanted devices that monitor pulmonary arterial pressure and/or other parameters may be beneficial in selected patients or when used in structured programs, but the value of these devices in routine care requires further study.”
U.S. Preventive Services Task Force Recommendations
Thoracic electrical bioimpedance, TEB, impedance cardiography, ICD, cardiac output, CO, thermodilution, inert gas rebreathing, BioZ®, Innocor, VeriCor®, Endosure®, Implantable Direct Pulmonary Artery Pressure, Left Ventricular End Diastolic Pressure, LVEDP, Noninvasive Measurement, CardioMEMS, thoracic bioimpedance, TEBCO®, IQ™, Zoe®, Cheetah NICOM®, PhysioFlow®, Cardiography, ZOLL, MicroCor, uCor, HFAMS, Heart Failure and Arrhythmia Management System
APPROVED BY GOVERNING BODIES:
Noninvasive Left Ventricular End Diastolic Pressure Measurement Devices
In June 2004, the VeriCor® (CVP Diagnostics, Boston, MA), a noninvasive left ventricular end diastolic pressure measurement device, was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The FDA determined that this device was substantially equivalent to existing devices for the following indication:
“The VeriCor is indicated for use in estimating non-invasively, left ventricular end-diastolic pressure (LVEDP). This estimate, when used along with clinical signs and symptoms and other patient test results, including weights on a daily basis, can aid the clinician in the selection of further diagnostic tests in the process of reaching a diagnosis and formulating a therapeutic plan when abnormalities of intravascular volume are suspected. The device has been clinically validated in males only. Use of the device in females has not been investigated.”
Thoracic Bioimpedance Devices
Multiple thoracic impedance measurement devices that do not require invasive placement have been cleared for marketing by the U.S. Food and Drug Administration (FDA) 510(k) process. FDA determined that this device was substantially equivalent to existing devices for use for peripheral blood flow monitoring. Table 1 includes a representative list of devices, but is not meant to be comprehensive (FDA product code: DSB).
Table 1: Noninvasive Thoracic Impedance Plethysmography Devices
Year of FDA Clearance
BioZ ® Thoracic Impedance Plethysmograph
SonoSite (Bothell, WA)
Zoe® Fluid Status Monitor
Noninvasive Medical Technologies LLC (Las Vegas, NV)
Cheetah Starling SV
Cheetah Medical Inc.
Physioflow® Signal Morphology-based Impedance Cardiography (SM-ICG™)
Vasocom Inc., now Neumedx Inc. (Bristol, PA)
ReDSTM Wearable System
Sensible Medical Innovations (Philadelphia, PA)
FDA: U.S. Food and Drug Administration.
In addition, several manufacturers market thoracic impedance measurement devices that are integrated into implantable devices.
Non-invasive Pulmonary Fluid Monitoring
In May 2018, the ZOLL uCor (MicroCor) Heart Failure and Arrhythmia Management System (HFAMS) was approved by the FDA through the 510(k) process. The device is described as a “wireless system that employs novel radiofrequency technology to monitor pulmonary fluid levels…ZOLL HFAMS continuously records, stores, and transmits patient data, including Thoracic Fluid Index, heart rate, respiration rate, activity, posture, and heart rhythm.”
Inert Gas Rebreathing Devices
In March 2006, the Innocor® (Innovision, Denmark), an inert gas rebreathing device, was cleared for marketing by FDA through the 510(k) process. FDA determined that this device was substantially equivalent to existing inert gas rebreathing devices for use in computing blood flow. FDA product code: BZG.
Implantable Pulmonary Artery Pressure Sensor Devices
In May 2014, the CardioMEMS™ Champion Heart Failure Monitoring System (CardioMEMS, now Abbott) was approved for marketing by FDA through the premarket approval process. This device consists of an implantable pulmonary artery (PA) sensor, which is implanted in the distal PA, a transvenous delivery system, and an electronic sensor that processes signals from the implantable PA sensor and transmits PA pressure measurements to a secure database. The device originally underwent FDA review in 2011, at which point FDA decided that there was no reasonable assurance that the discussed monitoring system would be effective, particularly in certain subpopulations, although it was agreed that this monitoring system was safe for use in the indicated patient population.
Several other devices that monitor cardiac output by measuring pressure changes in the PA or right ventricular outflow tract have been investigated in the research setting but have not received FDA approval. They include the Chronicle® implantable continuous hemodynamic monitoring device (Medtronic, Minneapolis, MN), which includes a sensor implanted in the right ventricular outflow tract, and the ImPressure® device (Remon Medical Technologies, Caesara, Israel), which includes a sensor implanted in the PA.
Note: This evidence review only addresses use of these techniques in ambulatory care and outpatient settings.
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply
FEP: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.
Transcatheter implantation of wireless pulmonary artery pressure sensor for long-term hemodynamic monitoring, including deployment and calibration of the sensor, right heart catheterization, selective pulmonary catheterization, radiological supervision and interpretation, and pulmonary artery angiography, when performed (Effective 01/01/2019)
Remote monitoring of a wireless pulmonary artery pressure sensor for up to 30 days, including at least weekly downloads of pulmonary artery pressure recordings, interpretation(s), trend analysis, and report(s) by a physician or other qualified health care professional (Effective 01/01/2019)
There is a specific CPT code for bioimpedance:
Bioimpedance-derived physiologic cardiovascular analysis
There is a specific CPT code for non-invasive pulmonary monitoring:
Remote monitoring of an external continuous pulmonary fluid monitoring system, including measurement of radiofrequency-derived pulmonary fluid levels, heart rate, respiration rate, activity, posture, and cardiovascular rhythm (e.g., ECG data), transmitted to a remote 24-hour attended surveillance center; set-up and patient education on use of equipment (Effective 07/01/2020)
analysis of data received and transmission of reports to the physician or other qualified health care professional (Effective 07/01/2020)
Inert gas rebreathing measurement and LVEDP should be reported using the unlisted code 93799.
There is no specific CPT code for implantable direct pressure monitoring of the pulmonary artery. The unlisted code 93799 would be used.
Unlisted cardiovascular service or procedure
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- Abraham WT, Adamson PB, Bourge RC et al. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial. Lancet 2011; 377(9766):658-66.
- Abraham WT, Adamson PB, Bourge RC, et al. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial. Lancet 2011; 377(9766):658-66.
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- Adamson PB, Abraham WT, Stevenson LW, et al. Pulmonary artery pressure-guided heart failure management reduces 30-day readmissions. Circ Heart Fail. Jun 2016;9(6).
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- Anand IS, Greenberg BH, Fogoros RN et al. Design of the Multi-Sensor Monitoring in Congestive Heart Failure (MUSIC) study: prospective trial to assess the utility of continuous wireless physiologic monitoring in heart failure. Journal of cardiac failure 2011; 17(1):11-6.
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- CardioMEMSChampion™ Heart Failure Monitoring System: Presentation - CardioMEMS: Oct. 9, 2013. 2013; https://wayback.archiveit.org/7993/20170111163201/http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM370951.pdf. Accessed April 17, 2018.
- CardioMEMS Champion™ HF Monitoring System: FDA Review of P100045/A004FDA Presentation - CardioMEMS: Oct. 9, 2013. 2013; https://wayback.archiveit.org/7993/20170111163259/http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM370955.pdf. Accessed April 17, 2018.
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- Christensen P, et al. Thermodilution versus inert gas rebreathing for estimation of effective pulmonary blood flow, Critical Care Medicine, January 2000; 28(1): 51-56.
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- DeMaria, A. et al. Comparative overview of cardiac output measurement methods: Has impedance cardiography come of age?, Congestive Heart Failure, March-April 2000; 6(2): 60-73. (Abstract)
- DeMaria, A. et al. The COST study: A multicenter trial comparing measurement of cardiac output by thoracic electrical bioimpedance with thermodilution, Presentation at the American College of Cardiology 47th Annual Scientific Session, April 1, 1998. (Abstract)
- Desai AS, Bhimaraj A, Bharmi R, et al. Ambulatory hemodynamic monitoring reduces heart failure hospitalizations in "real-world" clinical practice. J Am Coll Cardiol. May 16 2017;69(19):2357-2365.
- Dickinson, MM, Allen, LL, Albert, NN, DiSalvo, TT, Ewald, GG, Vest, AA, Whellan, DD, Zile, MM, Givertz, MM. Remote Monitoring of Patients With Heart Failure: A White Paper From the Heart Failure Society of America Scientific Statements Committee.. J. Card. Fail., 2018 Oct 12;24(10).
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- Dueck, R. et al. Noninvasive cardiac output monitoring, Chest, August 2001, Vol. 120, No. 2.
- Durkin RJ, et al. Noninvasive estimation of pulmonary vascular resistance by stroke index measurement with an inert gas rebreathing technique, Chest, July 1994; 106(1): 59-66.
- FDA. Summary of Safety and Effectiveness Data (SSED) -- CardioMEMS HF System. 2014. Available online at: www.accessdata.fda.gov/cdrh_docs/pdf10/P100045b.pdf. Last accessed March 19, 2020.
- FDA. 510(k) Clearances. Available at: https://www.fda.gov/medical-devices/510k-clearances/may-2018-510k-clearances.
- Givertz MM, Stevenson LW, Costanzo MR, et al. Pulmonary Artery Pressure-Guided Management of Patients With Heart Failure and Reduced Ejection Fraction. J Am Coll Cardiol. Oct 10 2017;70(15):1875-1886.
- Hassan M, Wagdy K, Kharabish A, et al. Validation of Noninvasive Measurement of Cardiac Output Using Inert Gas Rebreathing in a Cohort of Patients With Heart Failure and Reduced Ejection Fraction. Circ Heart Fail. Mar 2017; 10(3).
- Heist EK, Herre JM, Binkley PF, et al. Analysis of different device-based intrathoracic impedance vectors for detection of heart failure events (from the Detect Fluid Early from Intrathoracic Impedance Monitoring study). Am J Cardiol. Oct 15 2014; 114(8):1249-1256.
- Heywood JT, Jermyn R, Shavelle D et al. Impact of practice-based management of pulmonary artery pressures in 2000 patients implanted with the CardioMEMS Sensor. Circulation. 2017 Apr 18; 135(16): 1509-1517.
- Hirschl, M. et al. Simultaneous comparison of thoracic bioimpedance and arterial pulse waveform-derived cardiac output with thermodilution measurement, Critical Care Medicine, June 2000, Vol., 28, No., 6, pp. 1798-1802.
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- Krahnke JS, Abraham WT, Adamson PB, et al. Heart failure and respiratory hospitalizations are reduced in patients with heart failure and chronic obstructive pulmonary disease with the use of an implantable pulmonary artery pressure monitoring device. J Card Fail. Mar 2015; 21(3):240-249.
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Medical Policy Group, July 2010 (1)
Medical Policy Administration Committee, July 2010
Available for comment July 23-September 6, 2010
Medical Policy Group, July 2011 (1): Update to Key Points, Approved by Governing Bodies and References
Medical Policy Group, August 2011 (1): Merge policy #363 onto this policy related to non-invasive measurement of LVEDP in outpatient setting and archive policy #363
Medical Policy Administration Committee, August 2011
Medical Policy Group, July 2012 (1): Update to Key Points and References related to MPP update; no change to policy statement
Medical Policy Group, July 2013 (4): 2013 Update to Description, Key Points and References
Medical Policy Panel, July 2014
Medical Policy Group, July 2014 (4): 2014 Update to Description, Approved Governing Bodies, Key Points, Key Words, & References; no change in policy statement
Medical Policy Group, September 2014 (3): October Quarterly Coding Update – added to current coding section code C9741 & description with effective date 10/1/14
Medical Policy Group, November 2014: Annual Coding update. Added HCPC code C2624 to current coding, effective date01/01/15; also updated C9741 with the removal of “includes provision of patient home electronics unit”.
Medical Policy Panel, July 2015
Medical Policy Group, July 2015(4): Updates to Description, Key Points, Key Words and References. No change to policy statement.
Medical Policy Panel, May 2016
Medical Policy Group, May 2016 (4): Updates to Description, Key Points and References. No change to policy statement.
Medical Policy Panel, May 2017
Medical Policy Group, June 2017 (4): Updates to Description, Key Points, Approved by Governing Bodies, Coding and References. No change to policy statement. Removed Previous CPT coding 0104T and 0105T that were deleted 1/1/11 and removed HCPCs codes C2624 and C9741.
Medical Policy Panel, May 2018
Medical Policy Group, May 2018 (4): Updates to Description, Key Points, Approved by Governing Bodies, and References. No change to policy statement.
Medical Policy Group, December 2018: 2019 Annual Coding Update. Added CPT codes 33289, 93264 to the Current Coding section.
Medical Policy Panel, May 2019
Medical Policy Group, May 2019 (4): Updates to Description, Key Points, and References. No change to policy statement.
Medical Policy Panel, May 2020
Medical Policy Group, June 2020 (4): Updates to Policy, Key Points, Key Words, Approved by Governing Bodies, Coding, and References. Added “non-invasive pulmonary fluid monitoring” to policy statement. Added Key Words: ZOLL, MicroCor, uCor, HFAMS, Heart Failure and Arrhythmia Management System. Added new CPT code 0607T and 0608T to Current Coding.
Medical Policy Administration Committee, July 2020
This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.
The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.
As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.
The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:
1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.
Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.